On December 4, 2019, the FDA announced that ongoing testing of OTC and prescription ranitidine (commonly known as Zantac) and nizatidine products is required due to the detection of an N-nitrosodimethylamine (NDMA) impurity, following up on its September 2019 statement. In addition, the FDA has investigated NDMA impurities found in metformin diabetes drugs outside the U.S. Collectively, the attention on NDMA from regulatory bodies has led to increased efforts to evaluate drugs for possible nitrosamine contamination (including NDMA and the related NDEA or N-nitrosodiethylamine), even stimulating AstraZeneca to electively evaluate its entire drug portfolio.
NDMA Impurity Testing in Ranitidine (Zantac), Nizatidine, and Metformin
The FDA’s investigations sought to:
- Understand the source of the NDMA impurity in common heartburn and diabetes medications
- Provide information to patients and consumers
The FDA asked manufacturers to conduct their own laboratory testing to identify levels of NDMA, and also asked them to submit samples to be tested by FDA scientists.
As of April 1, 2020, the FDA asked all manufacturers to immediately recall all prescription and OTC ranitidine drugs. Furthermore, several metformin drugs have also been recalled as of June 2020.
Further NDMA Impurity Screening of Ranitidine and Nizatidine is Now Required
The FDA has asked manufacturers of ranitidine and nizatidine medications to expand testing for NDMA to all lots prior to making the product available to consumers and patients.
If NDMA is found to be above the acceptable daily intake limit, the manufacturer is obligated to inform the FDA and should not release the lot for consumer use. The acceptable daily intake limit for NDMA is 96 nanograms per day or 0.32 parts per million for ranitidine.
Bringing Medications Back to the Market with NDMA Testing
Several manufacturers have voluntarily recalled ranitidine medications, and information can be found on the FDA’s recall webpage. Some companies recalled medication due to levels of NDMA above the acceptable daily intake limit, and others recalled ranitidine drugs due to the potential of an NDMA impurity.
Manufacturers can establish levels of NDMA in ranitidine and nizatidine medications by testing each lot of product prior to release. If NDMA is found to be below the acceptable daily intake limit during lot release testing, their ranitidine medications may become available to patients and consumers.
Avomeen Nitrosamine Testing Service for Identifying NDMA Impurities in Pharmaceuticals
Avomeen’s industry and scientific experts have tested a number of lots for the FDA’s initial NDMA impurity investigation, and are ready to analyze lots of ranitidine, nizatidine, and metformin products to determine levels of NDMA and other nitrosamines prior to release to consumers and patients. In addition, we can apply our knowledge of nitrosamine impurities and analytical testing methods to investigate other pharmaceuticals for NDMA and NDEA contamination.
Looking for help with nitrosamine testing services and regulatory support?
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